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AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV) (AURA-LV)

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ClinicalTrials.gov Identifier: NCT02141672
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Voclosporin High Dose
Drug: Voclosporin Low Dose
Drug: Placebo
Enrollment 265
Recruitment Details  
Pre-assignment Details Eligible subjects were randomized in a ratio of 1:1:1 to receive either voclosporin 23.7 mg BID or 39.5 mg BID, or matching placebo for 48 weeks. All subjects were also to receive 2 g/day MMF. In addition, all subjects were to receive 0.5 g/day IV methylprednisolone on Days 1 and 2 before changing to a reducing course of oral corticosteroid therapy on Day 3.
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description Voclosporin oral 23.7 mg (3 capsules) BID Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID Placebo capsules matched to high dose or low dose voclosporin regimen.
Period Title: Overall Study
Started 89 88 88
Completed 73 80 70
Not Completed 16 8 18
Reason Not Completed
Adverse Event             0             1             0
Death             10             2             1
Lack of Efficacy             0             0             2
Lost to Follow-up             1             1             3
Physician Decision             1             2             5
Protocol Violation             0             0             1
Withdrawal by Subject             3             2             5
refused to follow-up             1             0             1
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo Total
Hide Arm/Group Description Voclosporin oral 23.7 mg (3 capsules) BID Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID Placebo capsules matched to high dose or low dose voclosporin regimen. Total of all reporting groups
Overall Number of Baseline Participants 89 88 88 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 88 participants 88 participants 265 participants
31.4  (11.78) 30.6  (9.59) 33.1  (10.03) 31.7  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 88 participants 265 participants
Female
76
  85.4%
81
  92.0%
73
  83.0%
230
  86.8%
Male
13
  14.6%
7
   8.0%
15
  17.0%
35
  13.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 88 participants 265 participants
Hispanic or Latino
9
  10.1%
13
  14.8%
13
  14.8%
35
  13.2%
Not Hispanic or Latino
80
  89.9%
75
  85.2%
75
  85.2%
230
  86.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 88 participants 265 participants
American Indian or Alaska Native
4
   4.5%
2
   2.3%
3
   3.4%
9
   3.4%
Asian
52
  58.4%
44
  50.0%
36
  40.9%
132
  49.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.4%
Black or African American
3
   3.4%
6
   6.8%
5
   5.7%
14
   5.3%
White
30
  33.7%
36
  40.9%
42
  47.7%
108
  40.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 88 participants 265 participants
United States 5 10 6 21
Bangladesh 17 16 13 46
Belarus 1 8 4 13
Bulgaria 2 1 2 5
Ecuador 2 1 2 5
Georgia 1 1 3 5
Guatemala 2 6 3 11
Hong Kong 0 0 1 1
South Korea 3 2 2 7
Mexico 3 3 8 14
Philippines 20 13 10 43
Poland 2 0 2 4
Russia 10 9 13 32
Serbia 4 1 7 12
Singapore 0 1 0 1
Spain 1 0 0 1
Sri Lanka 5 4 5 14
Taiwan 2 1 2 5
Thailand 5 6 2 13
Ukraine 4 5 3 12
Lupus Nephritis history  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 88 participants 88 participants 265 participants
Years since diagnosis of LN (years) 4.2  (5.14) 3.2  (4.36) 3.5  (4.03) 3.7  (4.54)
Years since first significant proteinuria (years) 4.5  (5.53) 3.3  (4.22) 3.6  (4.06) 3.8  (4.66)
Lupus Nephritis history - Baseline UPCR  
Median (Standard Deviation)
Unit of measure:  Mg/mg
Number Analyzed 89 participants 88 participants 88 participants 265 participants
5.16  (4.15) 4.48  (3.03) 4.43  (3.58) 4.69  (3.6)
Lupus Nephritis history - Baseline eGFR  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m2
Number Analyzed 89 participants 88 participants 88 participants 265 participants
95.3  (28.4) 104  (27.3) 100.2  (27.05) 99.8  (27.71)
1.Primary Outcome
Title Number of Subjects Achieving Complete Renal Remission at 24 Weeks
Hide Description

Complete remission is defined as:

  • Confirmed protein/creatinine ratio of ≤0.5 mg/mg and
  • eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
Achieved response
29
  32.6%
24
  27.3%
17
  19.3%
Did not achieve response
60
  67.4%
64
  72.7%
71
  80.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.01 to 4.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
0.78 to 3.27
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects Achieving Complete Renal Remission at 48 Weeks
Hide Description

Complete remission is defined as:

  • Confirmed protein/creatinine ratio of ≤0.5 mg/mg and
  • eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
Achieved response
44
  49.4%
35
  39.8%
21
  23.9%
Did not achieve response
45
  50.6%
53
  60.2%
67
  76.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
1.68 to 6.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.09 to 4.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids
Hide Description

Complete remission is defined as:

  • Confirmed protein/creatinine ratio of ≤0.5 mg/mg and
  • eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.

Low-dose steroids is defined as use of ≤5 mg prednisone for 8 weeks leading up to the Week 24 visit date or for 12 weeks leading up to the Week 48 visit date.

Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
Achieved response at week 24
26
  29.2%
23
  26.1%
17
  19.3%
Achieved response at week 48
29
  32.6%
26
  29.5%
18
  20.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
0.96 to 3.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
0.82 to 3.28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Complete Remission (Number of Weeks)
Hide Description Time to Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg in the absence of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
19.7
(16.1 to 36.1)
23.4
(13.7 to 33.4)
NA [1] 
(48.1 to NA)
[1]
NA = insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
1.45 to 3.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
1.46 to 3.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Sustained Early Complete Remission (Number of Weeks)
Hide Description Time to Sustained Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(20.0 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.89
Confidence Interval (2-Sided) 95%
1.58 to 5.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.248
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
0.77 to 2.86
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Achieving Sustained Early Complete Remission
Hide Description Sustained early complete remission defined as complete remission that occurred on or before Week 24 and was sustained through Week 48
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
36
  40.4%
22
  25.0%
15
  17.0%
7.Secondary Outcome
Title Time to Partial Remission (Number of Weeks)
Hide Description Time to partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
4.3
(2.6 to 5.9)
4.4
(4.1 to 6.1)
6.6
(4.6 to 8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.16 to 2.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.25 to 2.43
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects Achieving Partial Remission
Hide Description Partial remission is defined as a 50% reduction in UPCR from baseline at Week 24 and Week 48.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
76
  85.4%
82
  93.2%
67
  76.1%
9.Secondary Outcome
Title Number of Subjects Achieving, and Remaining in, Complete Remission
Hide Description Sustained complete remission defined as the first occurrence of complete remission that was sustained through Week 48
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Participants Achieving Complete Remission
57
  64.0%
61
  69.3%
32
  36.4%
Number of Participants Remaining in Complete Remission
19
  21.3%
28
  31.8%
10
  11.4%
Number of Participants with Second Increase of UPCR >0.5 mg/mg
38
  42.7%
33
  37.5%
22
  25.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.980
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.45 to 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
0.95 to 4.16
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Duration of Complete Remission (Number of Weeks)
Hide Description Duration of Complete Remission is defined as time of first occurrence of UPCR ≤ 0.5 mg/mg until the second increase above 0.5 mg/mg (i.e. a single occurrence above 0.5 is permitted) or use of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
49
(42.1 to 49.0)
25 [1] 
(23.3 to NA)
NA [1] 
(26.3 to NA)
[1]
NA = insufficient number of participants with events
11.Secondary Outcome
Title Number of Subjects Achieving Partial Renal Remission at 24 and 48 Weeks
Hide Description Number of patients with partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction at week 24 or week 48 in the absence of rescue medication.
Time Frame week 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
Achieved partial remission at week 24
62
  69.7%
58
  65.9%
43
  48.9%
Achieved partial remission at week 48
61
  68.5%
63
  71.6%
42
  47.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.33
Confidence Interval (2-Sided) 95%
1.26 to 4.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.1 to 3.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
1.27 to 4.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments week 48
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
1.43 to 5.02
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to Sustained Partial Remission (Number of Weeks)
Hide Description Time to sustained partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
6.3
(4.0 to 11.9)
8.1
(6.1 to 16.6)
26.9 [1] 
(16.1 to NA)
[1]
NA = insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.36 to 3.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.22 to 2.69
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Subjects Achieving Sustained Partial Remission
Hide Description Sustained partial remission defined as the first occurrence of partial remission that was sustained through Week 48
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
61
  68.5%
63
  71.6%
42
  47.7%
14.Secondary Outcome
Title Time to Sustained Early Partial Remission (Number of Weeks)
Hide Description Time to sustained early partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Median (95% Confidence Interval)
Unit of Measure: weeks
6.3
(4.0 to 11.9)
8.1
(6.1 to 16.6)
NA [1] 
(16.1 to NA)
[1]
NA = insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Voclosporin Low Dose
Comments Voclosporin low dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.45 to 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Voclosporin High Dose
Comments Voclosporin high dose vs. placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
1.23 to 2.84
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Subjects Achieving Sustained Early Partial Remission
Hide Description Early partial remission defined as partial remission that occurred on or before Week 24 and was sustained through Week 48
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Measure Type: Count of Participants
Unit of Measure: Participants
60
  67.4%
58
  65.9%
36
  40.9%
16.Secondary Outcome
Title Change From Baseline in UPCR at Weeks 24 and 48
Hide Description Change from baseline in urine protein creatinine ratio at weeks 24 and 48
Time Frame Baseline, Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Mean (Standard Deviation)
Unit of Measure: mg/mg
Baseline UPCR 5.161  (4.151) 4.476  (3.029) 4.433  (3.58)
week 24 UPCR 1.021  (1.2369) 1.356  (1.5204) 2.266  (2.8534)
CFB at week 24 -3.769  (3.351) -2.792  (2.6207) -2.216  (3.9284)
week 48 UPCR 0.689  (0.9172) 1.101  (1.3835) 1.763  (1.9927)
CFB at week 48 -3.998  (3.4208) -2.993  (2.6608) -2.384  (3.454)
17.Secondary Outcome
Title Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score
Hide Description The SELENA-SLEDAI assesses disease activity within the last 10 days. Twenty-four items are scored for nine organ systems, and summed to a maximum of 105 points. A score of 6 is considered clinically significant and indicates active disease. For analysis purposes, a score ≥6 was categorized as "high". The 24 items are as follows: seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, and leukopenia.
Time Frame Baseline, Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description:
Voclosporin oral 23.7 mg (3 capsules) BID
Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID
Placebo capsules matched to high dose or low dose voclosporin regimen.
Overall Number of Participants Analyzed 89 88 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
SELENA-SLEDAI Score at baseline 12.7  (6.37) 13.9  (6.51) 12.9  (6.57)
SELENA-SLEDAI Score at week 24 6.2  (4.53) 6.5  (5.42) 8.8  (5.43)
SELENA-SLEDAI Score change from baseline at week 24 -6.3  (5.86) -7.1  (7.41) -4.5  (7.09)
SELENA-SLEDAI Score at week 48 4.7  (5.06) 5.3  (3.97) 7.8  (5.93)
SELENA-SLEDAI Score Change from baseline at week 48 -7.9  (6.39) -8.3  (6.93) -5.3  (6.85)
Time Frame Week 52
Adverse Event Reporting Description Treatment emergent AEs. Reporting period is from first dose up to 30 days after study completion or withdrawal
 
Arm/Group Title Voclosporin Low Dose Voclosporin High Dose Placebo
Hide Arm/Group Description Voclosporin oral 23.7 mg (3 capsules) BID Voclosporin oral 23.7 mg BID until week 2 followed by 39.5 mg (5 capsules) BID Placebo capsules matched to high dose or low dose voclosporin regimen.
All-Cause Mortality
Voclosporin Low Dose Voclosporin High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/89 (11.24%)   2/88 (2.27%)   1/88 (1.14%) 
Hide Serious Adverse Events
Voclosporin Low Dose Voclosporin High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/89 (28.09%)   22/88 (25.00%)   14/88 (15.91%) 
Blood and lymphatic system disorders       
Iron Deficiency Anaemia  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Anaemia  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Hypochromic Anaemia  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Cardiac disorders       
Pericardial Effusion  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Pericarditis  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Cardiac Failure  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Cardiac Tamponade  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Acute Coronary Syndrome  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Congestive Cardiomyopathy  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Endocrine disorders       
Hypothyroidism  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Diabetes Mellitus Inadequate Control  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Gastrointestinal disorders       
Diarrhoea  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Gastritis Erosive  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Gastrointestinal Haemorrhage  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Peptic Ulcer  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Gastritis  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Gastrooesophageal Reflux Disorder  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
General disorders       
Pyrexia  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Multi-Organ Failure  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Hepatobiliary disorders       
Drug-Induced Liver Injury  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Immune system disorders       
Hypersensitivity  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Infections and infestations       
Pneumonia  1  5/89 (5.62%)  3/88 (3.41%)  2/88 (2.27%) 
Gastroenteritis  1  1/89 (1.12%)  2/88 (2.27%)  1/88 (1.14%) 
Sepsis  1  1/89 (1.12%)  2/88 (2.27%)  0/88 (0.00%) 
Body Tinea  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Urinary Tract Infection  1  2/89 (2.25%)  1/88 (1.14%)  0/88 (0.00%) 
Cellulitis  1  1/89 (1.12%)  1/88 (1.14%)  1/88 (1.14%) 
Herpes Zoster  1  0/89 (0.00%)  1/88 (1.14%)  1/88 (1.14%) 
Bacterial Pyelonephritis  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Bacterial Sepsis  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Bronchitis  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Subcutaneous Abcess  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Tuberculosis of Genitourinary System  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Viral Upper Respiratory Tract Infection  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Dengue Fever  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Pericarditis Tuberculous  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Pneumonia Bacterial  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Skin Infection  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Bronchiolitis  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Escherichia Urinary Tract Infection  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Gastroenteritis Viral  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Injury, poisoning and procedural complications       
Procedural Pain  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Metabolism and nutrition disorders       
Diabetes Mellitus  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Musculoskeletal and connective tissue disorders       
Systemic Lupus Erythematosus  1  1/89 (1.12%)  2/88 (2.27%)  2/88 (2.27%) 
Costochondritis  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Nervous system disorders       
Posterior Reversible Encephalitis Syndrome  1  2/89 (2.25%)  2/88 (2.27%)  0/88 (0.00%) 
Intracranial Pressure Increased  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Migraine  1  0/89 (0.00%)  1/88 (1.14%)  0/88 (0.00%) 
Cerebral Hemorrhage  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Convulsion  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Cerebrovascular Accident  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Renal and urinary disorders       
Renal Failure Acute  1  4/89 (4.49%)  1/88 (1.14%)  0/88 (0.00%) 
Renal Impairment  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Strangury  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Reproductive system and breast disorders       
Uterine Prolapse  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Dysfunctional Uterine Bleeding  1  0/89 (0.00%)  0/88 (0.00%)  1/88 (1.14%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism  1  2/89 (2.25%)  1/88 (1.14%)  0/88 (0.00%) 
Acute Respiratory Distress Syndrome  1  2/89 (2.25%)  0/88 (0.00%)  0/88 (0.00%) 
Pulmonary Alveolar Haemorrhage  1  1/89 (1.12%)  0/88 (0.00%)  0/88 (0.00%) 
Vascular disorders       
Hypertension  1  2/89 (2.25%)  2/88 (2.27%)  0/88 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Voclosporin Low Dose Voclosporin High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   82/89 (92.13%)   85/88 (96.59%)   75/88 (85.23%) 
Blood and lymphatic system disorders       
Anaemia  1  13/89 (14.61%)  14/88 (15.91%)  7/88 (7.95%) 
Leukopenia  1  1/89 (1.12%)  3/88 (3.41%)  6/88 (6.82%) 
Cardiac disorders       
Tachycardia  1  2/89 (2.25%)  5/88 (5.68%)  1/88 (1.14%) 
Gastrointestinal disorders       
Diarrhoea  1  16/89 (17.98%)  14/88 (15.91%)  14/88 (15.91%) 
Nausea  1  16/89 (17.98%)  11/88 (12.50%)  7/88 (7.95%) 
Vomiting  1  15/89 (16.85%)  9/88 (10.23%)  10/88 (11.36%) 
Dyspepsia  1  6/89 (6.74%)  6/88 (6.82%)  4/88 (4.55%) 
Abdominal Pain Upper  1  5/89 (5.62%)  7/88 (7.95%)  5/88 (5.68%) 
Gingival Hypertrophy  1  3/89 (3.37%)  6/88 (6.82%)  0/88 (0.00%) 
General disorders       
Oedema Peripheral  1  9/89 (10.11%)  7/88 (7.95%)  8/88 (9.09%) 
Pyrexia  1  6/89 (6.74%)  9/88 (10.23%)  1/88 (1.14%) 
Oedema  1  2/89 (2.25%)  5/88 (5.68%)  1/88 (1.14%) 
Immune system disorders       
Gastroenteritis  1  5/89 (5.62%)  3/88 (3.41%)  1/88 (1.14%) 
Infections and infestations       
Upper Respiratory Tract Infection  1  12/89 (13.48%)  18/88 (20.45%)  14/88 (15.91%) 
Urinary Tract Infection  1  6/89 (6.74%)  6/88 (6.82%)  5/88 (5.68%) 
Herpes Zoster  1  5/89 (5.62%)  6/88 (6.82%)  5/88 (5.68%) 
Nasopharyngitis  1  5/89 (5.62%)  4/88 (4.55%)  3/88 (3.41%) 
Gastroenteritis  1  5/89 (5.62%)  3/88 (3.41%)  1/88 (1.14%) 
Bronchitis  1  2/89 (2.25%)  5/88 (5.68%)  3/88 (3.41%) 
Oral Candidiasis  1  2/89 (2.25%)  5/88 (5.68%)  0/88 (0.00%) 
Investigations       
Glomerular Filtration Rate Decreased  1  27/89 (30.34%)  27/88 (30.68%)  12/88 (13.64%) 
Blood Pressure Increased  1  3/89 (3.37%)  5/88 (5.68%)  1/88 (1.14%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  12/89 (13.48%)  12/88 (13.64%)  9/88 (10.23%) 
Decreased Appetite  1  7/89 (7.87%)  5/88 (5.68%)  2/88 (2.27%) 
Dyslipidamia  1  6/89 (6.74%)  7/88 (7.95%)  6/88 (6.82%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  9/89 (10.11%)  7/88 (7.95%)  7/88 (7.95%) 
Back Pain  1  8/89 (8.99%)  5/88 (5.68%)  3/88 (3.41%) 
Muscle Spasms  1  5/89 (5.62%)  2/88 (2.27%)  3/88 (3.41%) 
Nervous system disorders       
Headache  1  10/89 (11.24%)  15/88 (17.05%)  11/88 (12.50%) 
Dizziness  1  5/89 (5.62%)  2/88 (2.27%)  1/88 (1.14%) 
Psychiatric disorders       
Insomnia  1  4/89 (4.49%)  5/88 (5.68%)  4/88 (4.55%) 
Renal and urinary disorders       
Renal Failure Acute  1  1/89 (1.12%)  7/88 (7.95%)  0/88 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  16/89 (17.98%)  5/88 (5.68%)  3/88 (3.41%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  7/89 (7.87%)  4/88 (4.55%)  2/88 (2.27%) 
Hypertrichosis  1  3/89 (3.37%)  7/88 (7.95%)  0/88 (0.00%) 
Vascular disorders       
Hypertension  1  15/89 (16.85%)  14/88 (15.91%)  8/88 (9.09%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rashieda Gluck
Organization: Aurinia Pharmaceuticals
Phone: 1 (250) 744-2487
EMail: clinicaltrials@auriniapharma.com
Layout table for additonal information
Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02141672    
Other Study ID Numbers: AUR-VCS-2012-01
First Submitted: May 14, 2014
First Posted: May 19, 2014
Results First Submitted: February 19, 2021
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021